BIRMINGHAM HIP RESURFACING MODULAR HEAD — Class II medical device recall Z-0584-2016
Terminated recall by Smith & Nephew, Inc., reported 2016-01-13, distributed nationwide. The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modul
| Recall number | Z-0584-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2015-11-16 |
| Classified | 2016-01-04 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, DE, DK, ES, FI, FR, GB, HK, IL, IN, IT, JP, KR, NL, NO, PL, PT, SE, SG, TH, TR, ZA |
| Quantity | 16 units |
| Reason classes | labeling, unapproved product |
| Model numbers | 74121238 |
Product
BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM -8MM 74121258, MODULAR HEAD 58 MM -8MM 74121338, MODULAR HEAD 3 8MM -4 (SHORT) 74121342, MODULAR HEAD 42 MM -4 (SHORT) 74121346, MODULAR HEAD 46 MM -4 (SHORT) 74121350, MODULAR HEAD 50 MM -4 (SHORT) 74121354, MODULAR HEAD 54 MM -4 (SHORT) 74121358, MODULAR HEAD 58 MM -4 (SHORT) 74121438, MODULAR HEAD 38 MM +0 (MED) 74121442, MODULAR HEAD 42 MM +0 (MED) 74121446, MODULAR HEAD 46 MM +0 (MED) 74121450, MODULAR HEAD 50 MM +0 (MED) 74121454, MODULAR HEAD 54 MM +0 (MED) 74121458, MODULAR HEAD 58 MM +0 (MED) 74121538, MODULAR HEAD 38 MM +4 (LONG) 74121542, MODULAR HEAD 42 MM +4 (LONG) 74121546, MODULAR HEAD 46 MM +4 (LONG) 74121550, MODULAR HEAD 50 MM +4 (LONG) 74121554, MODULAR HEAD 54 MM +4 (LONG) 74121558, MODULAR HEAD 58 MM +4 (LONG)
Reason for recall
The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0584-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.